Events

Recall of BD CD64 APCR700

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton, Dickinson and Company, BD Biosciences.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72548
  • Event Risk Class
    Class 2
  • Event Number
    Z-0334-2016
  • Event Initiated Date
    2015-10-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141497
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Reagents,specific,analyte - Product Code MVU
  • Reason
    Three lots of cd64 (md22) are contaminated with cd4 antibody.
  • Action
    Urgent Product Recall letters were sent out on October 30, 2015 via certified mail to notify customers of the issue.

Device

BD CD64 APCR700
  • Model / Serial
    Model 657701; Lot No. 4344945, 5037611, both with expiry date of 31 DEC 2015; and 5063945 with expiry dte of 29 FEB 2016.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.
  • Product Description
    BD CD64 APC-R700; || Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. || Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.
  • Manufacturer
    Becton, Dickinson and Company, BD Biosciences

Manufacturer

Becton, Dickinson and Company, BD Biosciences
  • Manufacturer Address
    Becton, Dickinson and Company, BD Biosciences, 2350 Qume Dr, San Jose CA 95131-1812
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA